MegaNatural (R)-BP grape seed extract and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 - Université de Lille Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 2021

MegaNatural (R)-BP grape seed extract and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

J. Castenmiller
  • Fonction : Auteur
S. de Henauw
  • Fonction : Auteur
K. I. Hirsch-Ernst
  • Fonction : Auteur
H. K. Knutsen
  • Fonction : Auteur
A. Maciuk
  • Fonction : Auteur
I. Mangelsdorf
  • Fonction : Auteur
H. J. Mcardle
  • Fonction : Auteur
A. Naska
  • Fonction : Auteur
C. Pelaez
  • Fonction : Auteur
K. Pentieva
  • Fonction : Auteur
A. Siani
  • Fonction : Auteur
F. Thies
  • Fonction : Auteur
S. Tsabouri
  • Fonction : Auteur
M. Vinceti
  • Fonction : Auteur

Résumé

Following an application from Praline i Cokolada j.d.o.o. submitted for authorisation of a health claimpursuant to Article 13(5) of Regulation (EC) No 1924/2006viathe Competent Authority of Croatia, theEFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion onthe scientific substantiation of a health claim related to MegaNatural®-BP grape seed extract andmaintenance of normal blood pressure. The scope of the application was proposed to fall under ahealth claim based on newly developed scientific evidence. MegaNatural®-BP, a grape seed extractstandardised for total phenolics, gallic acid and the catechin and epicatechin content, is sufficientlycharacterised. The proposed claimed effect, maintenance of normal blood pressure (BP), is a beneficialphysiological effect. Among the two human intervention studies provided from which conclusions couldbe drawn, one showed an effect of MegaNatural®-BP (300 mg/day) on BP in adults with normal andhigh normal BP when consumed daily for 6 weeks, whereas the second study did not show an effectof MegaNatural®-BP at the same daily dose consumed for 8 weeks in adults with normal and highnormal blood pressure or stage 1 hypertension. The evidence provided did not establish a plausiblemechanism by which the food could exert the claimed effectin vivoin humans. The evidence providedis insufficient to establish a cause and effect relationship between the consumption of MegaNatural®-BP and maintenance of normal blood pressure.
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Dates et versions

hal-04485436 , version 1 (01-03-2024)

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Dominique Turck, T. Bohn, J. Castenmiller, S. de Henauw, K. I. Hirsch-Ernst, et al.. MegaNatural (R)-BP grape seed extract and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal, 2021, EFSA Journal, 19, ⟨10.2903/j.efsa.2021.6776⟩. ⟨hal-04485436⟩

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